Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001471279
Ethics application status
Approved
Date submitted
29/08/2018
Date registered
3/09/2018
Date last updated
9/05/2024
Date data sharing statement initially provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Internal Evaluation of Prototype Mask Systems: Comparison of Cushions, Frames, Headgear, Components and Accessories
Scientific title
In healthy volunteers, do novel continuous positive airway
pressure (CPAP) masks, compared to commercially available CPAP masks, improve the subjective comfort, seal, stability, and general usability of CPAP therapy
Secondary ID [1] 295948 0
MA240818 & SLP-23-04-03
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked to ACTRN12614000999639. The current study is a continuation of the processes described in ACTRN12614000999639 with a new PI, new ethics submission, and minor protocol updates to align with new global clinical trial regulations

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 309451 0
Condition category
Condition code
Respiratory 308292 308292 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As this study protocol aims to facilitate the product development of CPAP masks (an iterative process), this protocol allows for a prototype mask to be designed, used as a trial intervention, improved based on patient feedback, and then retested again as trial intervention. This process may occur for several cycles. This particular protocol also allows for the testing of several different prototype masks. As such, the total number of intervention masks that may be evaluated will not be known at the beginning of the study, but will be reported at the completion of the study.

A variety of unregistered prototype CPAP masks will be used as the intervention in this study. The number of intervention masks that an individual participant may test will range from 1 to 2 masks. There will be no washout period between masks. CPAP masks may be full face, nasal, or nasal pillows masks (covering mouth and nose, covering nose only, or inserted into nostrils). Participants will also use an approved CPAP machine and humidifier with the prototype mask. CPAP pressure will be set to 12cmH2O or to a pressure that the participant feels most comfortable. Humidifier settings will be set to a level each participant feels most comfortable with.
ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients.

The sample size is the approximate sample size that will be recruited per prototype trial.
All CPAP masks will be used for a minimum of 3 nights and a maximum of 7 nights each.

Adherence will be monitored through data downloads directly from the patient's device or SD card. Adherence may also be monitored through an approved wireless therapy monitoring system (EasyCare Online).
Intervention code [1] 312271 0
Treatment: Devices
Comparator / control treatment
The comparator for this study will be one or more of the following:
- commercially available, approved CPAP mask
- another unapproved CPAP mask

The number of intervention masks that an individual participant may test will range from 1 to 2 masks. There will be no washout period between masks.
Control group
Active

Outcomes
Primary outcome [1] 307262 0
A composite score of subjective mask usability (comfort, seal, ease of use) as assessed by participant questionnaires (ie. 11-point Likert scale designed for this study). .
Timepoint [1] 307262 0
After maximum of 7 nights on CPAP mask
Secondary outcome [1] 351303 0
Mask leak, taken from CPAP download
Timepoint [1] 351303 0
After a maximum of 7 nights on CPAP

Eligibility
Key inclusion criteria
Inclusion Criteria (MA17082018)
• Participants who are employees of ResMed
• Participants who are willing to give written informed consent (signed paper copy or via DocuSign)
• Participants that are willing and able to complete the specified tasks
• Participants who are at least 18 years of age

Inclusion Criteria (SLP-23-04-02):
• Participants who are employees of ResMed
• Participants willing to give written informed consent
• Participants who > or = 18 years of age
• Participants willing and able to complete the specified tasks


Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria (MA17082018):
• Patients using Bilevel flow generators
• Patients who are or may be pregnant
• Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
• Patients believed to be unsuitable for inclusion by the researcher
• Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)


Exclusion Criteria (SLP-23-04-02):
• Participants who are or may be pregnant
• Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
• Participants who are unsuitable for inclusion in the opinion of the investigator
• Participants who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/09/2018
Actual
4/02/2019
Date of last participant enrolment
Anticipated
27/10/2028
Actual
Date of last data collection
Anticipated
10/11/2028
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300543 0
Commercial sector/Industry
Name [1] 300543 0
ResMed Ltd
Country [1] 300543 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Ltd
Address
1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2120
Country
Australia
Secondary sponsor category [1] 300028 0
None
Name [1] 300028 0
Address [1] 300028 0
Country [1] 300028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301339 0
UNSW HREC
Ethics committee address [1] 301339 0
Anzac Parade, Sydney, NSW, 2000
Ethics committee country [1] 301339 0
Australia
Date submitted for ethics approval [1] 301339 0
Approval date [1] 301339 0
09/11/2018
Ethics approval number [1] 301339 0
HC180734
Ethics committee name [2] 315263 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [2] 315263 0
https://research.unsw.edu.au/research-ethics-and-compliance-support-recs

UNSW HREC B, they now have 3 sub-committees (A, B & C)
Ethics committee country [2] 315263 0
Australia
Date submitted for ethics approval [2] 315263 0
23/06/2023
Approval date [2] 315263 0
25/08/2023
Ethics approval number [2] 315263 0
HC230402

Summary
Brief summary
Prototype CPAP masks will be evaluated for usability (comfort, seal and stability) by participants for a 7 night period. During the process of product development, multiple user trials are conducted in order to improve CPAP masks. The purpose of this study is to identify usability issues and improve them in order to develop CPAP masks which are comfortable and easy to use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86666 0
Dr Adam Benjafield
Address 86666 0
ResMed Ltd. 1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2120
Country 86666 0
Australia
Phone 86666 0
+61 2 8884 1000
Fax 86666 0
Email 86666 0
[email protected]
Contact person for public queries
Name 86667 0
Ms Alison Wimms
Address 86667 0
ResMed Ltd. 1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2120
Country 86667 0
Australia
Phone 86667 0
+61 2 8884 1000
Fax 86667 0
Email 86667 0
[email protected]
Contact person for scientific queries
Name 86668 0
Ms Alison Wimms
Address 86668 0
ResMed Ltd. 1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2120
Country 86668 0
Australia
Phone 86668 0
+61 2 8884 1000
Fax 86668 0
Email 86668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidential data, no benefit in sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.